Zheng Quan Shi Bao Wang·2025-04-25 10:38Core Viewpoint - The approval of the new BTK inhibitor, Oubatinib (brand name: Yinuokai), by the National Medical Products Administration (NMPA) in China for first-line treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) represents a significant advancement in the treatment options available for lymphoma patients [1] Group 1: Company Overview - Nocare Biopharma (stock codes: 688428 on SSE; 09969 on HKEX) is a biopharmaceutical high-tech company focused on the development of innovative drugs for malignant tumors and autoimmune diseases [3] - The company has multiple new drug products at various stages of commercialization, clinical trials, and preclinical research, with branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States [3] Group 2: Product Approval and Impact - Oubatinib has previously been approved in China for treating relapsed/refractory CLL/SLL, mantle cell lymphoma (R/R MCL), and marginal zone lymphoma (R/R MZL), all of which are included in the national medical insurance [1] - The first-line approval for CLL/SLL is expected to benefit a larger number of lymphoma patients, with clinical trials showing a complete remission rate of 12.1% [1] - Experts have highlighted Oubatinib's high selectivity and low off-target effects, which enhance its efficacy and safety in treating blood cancers [1] Group 3: Clinical Research and Expert Opinions - Clinical researchers noted that Oubatinib demonstrated significant efficacy and safety even during the challenges posed by the COVID-19 pandemic, confirming its innovative nature [1] - The drug has been included as a Class I recommendation in the CSCO lymphoma treatment guidelines for first-line therapy of CLL/SLL, indicating its recognized importance in clinical practice [1] - Experts anticipate that the accumulation of real-world data will further guide clinical practices and improve treatment options for more lymphoma patients [1]